A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)

A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating The Efficacy And Safety Of Multiple Treatment Combinations In Patients With Melanoma (MORPHEUS-MELANOMA).

This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naïve patients with resectable Stage III melanoma (Cohort 1) and in patients with Stage IV melanoma (Cohort 2).

  • Cohort 1: resectable Stage III melanoma (T: T0, Tx, or T14; N: cN13, pN1b/2b/3b; M: M0 according to AJCC-8) and no history of in-transit metastases within the last 6 months
  • Cohort 2: Stage IV (metastatic) cutaneous melanoma

The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity and modify the participant population.

Inclusions/Exclusions: ECOG 0-1. Negative HIV, HBV, HCV at screening. Measurable dx by RECIST. No mucosal or uveal melanoma, Acral permitted in cohort 2. No prior anit-LAG-3 for cohorts 1 & 2 with RO7247669 arm. No prior anti-TIGIT for cohort 1 & 2 with Tiragolumab arms.

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